Brain MappingNCT00884702
Regional Rates of Cerebral Protein Synthesis: Effects of Sleep and Memory Consolidation
An observational study of Brain Mapping, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: The brain needs sleep to function normally, but the purpose of sleep is not understood. Brain activity decreases during sleep, so it may be that sleep is important to maintain, repair, or reorganize brain cells. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Mapping
- How many people
- 538 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2009to 18 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers who have no present or past diagnosis of neurologic, medical or psychiatric conditions which may confound either learning trails, normal sleep patterns or the ability to undergo sleep deprivation.
- Healthy male and female subjects, 18-28 years of age, who do not meet any exclusion criteria, with self-reported normal sleep patterns (i.e., 6-9 h per night) and no major sleep disruptions during the four weeks prior to evaluation will be considered for inclusion in the study.
Who cannot join
- chronic medical condition which is a contraindication for PET or MRI scanning,
- past or present diagnosis of psychiatric conditions (DSM-IV criteria) (many conditions (e.g. depression), may confound performance on learning trails or be associated with baseline sleep abnormalities),
- chronic/degenerative/acquired neurologic disorder, (4) family history of genetically transmissible neurologic disorder,
- sleep disorders or medical conditions associated with chronically disordered sleep which may confound performance on learning trails or interfere with the sleep requirements of this study,
- visual impairments which may confound performance on learning trails,
- claustrophobic subjects,
Show all 14Show fewer
- subjects who meet the above inclusion criteria, but are unable to cooperate with the requirements of the study (e.g. refusal to wear actigraphs or maintain 10 hours time in bed, reported difficulty sleeping away from home or on their backs).
- Subjects with chronic indicated or non-indicated use of any medications which interfere with sleep architecture and/or learning trails will be excluded. Generally, we will prohibit the use of medications/agents (e.g. anti-histamines, benadryl, melatonin, cigarettes, chocolate, coffee, tea, caffeine drinks etc.), which have significant CNS penetration, are alerting, and/or disrupt physiologic sleep-wake cycles or sleep architecture, for the 72 hrs immediately preceding presentation for the study. To acclimatize subjects, we will encourage patients to discontinue or minimize the use of these agents/medications (e.g. less than or equal to 1 cup of coffee/day) at the time of initial screening (at the same time as actigraphy application, approximately 2 wks prior to the study).
- Similarly, we ask subjects to minimize alcohol use for the 2 wks prior to the study and will discontinue alcohol use for the 72 hrs immediately preceding the study.
- Subjects who have used illicit drugs (marijuana, cocaine, heroin, etc.) within the immediate 2 wks preceding the study.
- Female subjects will be excluded if either clinical history is suspicious for, or laboratory evaluation is consistent with pregnancy.
- Subjects unwilling to undergo HIV testing, unless enrolling in Part IIa of the study.
- Subjects who test HIV positive.
- Patients with para- and/or ferro-magnetic prosthesis/implants/fragments in their body will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- The brain needs sleep to function normally, but the purpose of sleep is not understood. Brain activity decreases during sleep, so it may be that sleep is important to maintain, repair, or reorganize brain cells. In animals, the formation of brain proteins increases during sleep, and the same thing may happen in humans.
- There is also evidence that learning and memory are helped by sleep, and that the synthesis of proteins in the brain are involved.
Read more
Objectives:
- To examine the formation of proteins in the brain while people are awake, deprived of sleep, and during sleep.
- To look at the formation of proteins in the brain while awake or asleep and following learning a task.
Eligibility:
- Healthy volunteers between 18 and 28 years of age.
- Volunteers must not have psychiatric, neurologic, or sleep disorders or certain types of vision problems, and must be able to undergo imaging studies.
Design:
- Study Part I (protein formation in waking, sleep deprivation, and sleep):
- Participants will wear an actigraph (a unit to record motor activity) for 2 weeks prior to admission.
- Participants will have physical and psychological examinations, along with a blood sample.
- After admission participants will have three positron emission tomography (PET) scans to study protein formation and one magnetic resonance imaging (MRI) scan over the course of two days.
- Participants may be asked to stay awake for as long as 20 hours and will be monitored throughout.
- Participants will be able to sleep overnight after they complete the required scans and monitoring, and will be discharged the following morning.
- Study Part II (protein formation in waking and sleep combined with a learning task):
- Participants will wear an actigraph (a unit to record motor activity) for 2 weeks prior to admission.
- Participants will have physical and psychological examinations, along with a blood sample.
- After admission participants may be asked to stay awake for as long as 20 hours and will be monitored throughout.
- The next morning, participants will be trained to perform a computerized visual discrimination task, and will be tested 8 hours later (after sleep or after remaining awake) on the visual discrimination task.
- Some participants may have PET and MRI scans as part of the study.
- Participants will be able to sleep overnight after they complete the required tests and scans, and will be discharged the following morning.
- Participants will receive financial compensation for their participation in these studies.
Read the detailed description
The importance of sleep is widely appreciated, but the actual function of sleep remains unknown. Sleep occurs in much of the animal kingdom, in all mammals and birds and even in some lower forms. Sleep deprivation impairs brain function, and in rats, total sleep deprivation for 2-3 weeks results in death. One hypothesized role of sleep is for restoration and reorganization of neuronal circuits. There is some indirect evidence that during sleep, when cerebral energy requirements are reduced, cell resources are diverted to protein synthesis for the restoration of structure and function. The objectives of the present study are: 1) to further define the relationship between regional rates of cerebral protein synthesis (rCPS) and sleep and 2) to ascertain whether sleep-dependent visual learning during slow wave sleep (SWS) results in increases in rCPS in the primary visual cortex. We propose to use a novel positron emission tomography (PET)-based technique to quantify regional rates of cerebral protein synthesis (rCPS) in young, adult, healthy volunteers. The first objective will be addressed in Part I in which we will study each subject under the following three conditions: 1) awake and sleep-sated, 2) awake and sleep-deprived, and 3) during SWS after sleep-deprivation. Our aim is to complete fully successful studies in 15 subjects. The second objective will be addressed in Part II in which we will assess the relationship between rCPS and sleep-dependent visual learning on a retinotopically specific task. Each participant will serve as his own control by comparing the trained primary visual cortex hemisphere with the untrained hemisphere to which comparable visual information is presented but without learning. In Part II we will study two groups of subjects: 1) One group will be studied during SWS following the training session; 2) The second group will be studied at the same interval following the training session but awake. Subjects will be monitored with polysomnography to identify the stages of sleep. Our aim in part II is to complete fully successful studies in 15 subjects in each of the two groups. We anticipate that the results of Part I will identify changes in rCPS in specific brain regions which are characteristic of SWS and results of Part II may reveal relationships between rCPS and memory consolidation during SWS.
- Conditions
- Brain Mapping
- Keywords
- Sleep, 14C-Leucine, Cerebral Protein Synthesis, Memory, Positron Emission Tomography (PET), HV, Healthy Volunteer
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional rates of cerebral protein synthesis
Measured: 48 hrs
Secondary outcomes (1)
Sleep state and performance on visual discrimination task.
Measured: 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study start16 Apr 2009
- Study completion18 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brain MappingStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Carolyn B Smith, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884702
- Sponsor's protocol ID
- 090123
- Other IDs
- 09-M-0123
- Status last verified
- 18 Apr 2017
- First submitted
- 18 Apr 2009
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Armitage R. Microarchitectural findings in sleep EEG in depression: diagnostic implications. Biol Psychiatry. 1995 Jan 15;37(2):72-84. doi: 10.1016/0006-3223(94)00082-E.
PubMed 7718683Bishu S, Schmidt KC, Burlin T, Channing M, Conant S, Huang T, Liu ZH, Qin M, Unterman A, Xia Z, Zametkin A, Herscovitch P, Smith CB. Regional rates of cerebral protein synthesis measured with L-[1-11C]leucine and PET in conscious, young adult men: normal values, variability, and reproducibility. J Cereb Blood Flow Metab. 2008 Aug;28(8):1502-13. doi: 10.1038/jcbfm.2008.43. Epub 2008 May 21.
PubMed 18493259Boyle PJ, Scott JC, Krentz AJ, Nagy RJ, Comstock E, Hoffman C. Diminished brain glucose metabolism is a significant determinant for falling rates of systemic glucose utilization during sleep in normal humans. J Clin Invest. 1994 Feb;93(2):529-35. doi: 10.1172/JCI117003.
PubMed 8113391McWhirter KK, Morrow AS, Lee BA, Bishu S, Zametkin AJ, Balkin TJ, Smith CB, Picchioni D. A PILOT STUDY ON THE ENCODING OF A PERCEPTUAL LEARNING TASK FOLLOWING SLEEP DEPRIVATION. Percept Mot Skills. 2015 Aug;121(1):80-93. doi: 10.2466/23.PMS.121c11x9. Epub 2015 Jul 30.
PubMed 26226287
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Rates of Cerebral Protein Synthesis: Effects of Sleep and Memory Consolidation
- ClinicalTrials.gov ID
- NCT00884702
- Acronym / sponsor ID
- 090123
- Conditions
- Brain Mapping
- Keywords
- Sleep, 14C-Leucine, Cerebral Protein Synthesis, Memory, Positron Emission Tomography (PET), HV, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 538 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 16 Apr 2009
- Study completion
- 18 Apr 2017
- First posted
- 21 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- The brain needs sleep to function normally, but the purpose of sleep is not understood. Brain activity decreases during sleep, so it may be that sleep is important to maintain, repair, or reorganize brain cells. In animals, the formation of brain proteins increases during sleep, and the same thing may happen in humans.
- There is also evidence that learning and memory are helped by sleep, and that the synthesis of proteins in the brain are involved.
Objectives:
- To examine the formation of proteins in the brain while people are awake, deprived of sleep, and during sleep.
- To look at the formation of proteins in the brain while awake or asleep and following learning a task.
Eligibility:
- Healthy volunteers between 18 and 28 years of age.
- Volunteers must not have psychiatric, neurologic, or sleep disorders or certain types of vision problems, and must be able to undergo imaging studies.
Design:
- Study Part I (protein formation in waking, sleep deprivation, and sleep):
- Participants will wear an actigraph (a unit to record motor activity) for 2 weeks prior to admission.
- Participants will have physical and psychological examinations, along with a blood sample.
- After admission participants will have three positron emission tomography (PET) scans to study protein formation and one magnetic resonance imaging (MRI) scan over the course of two days.
- Participants may be asked to stay awake for as long as 20 hours and will be monitored throughout.
- Participants will be able to sleep overnight after they complete the required scans and monitoring, and will be discharged the following morning.
- Study Part II (protein formation in waking and sleep combined with a learning task):
- Participants will wear an actigraph (a unit to record motor activity) for 2 weeks prior to admission.
- Participants will have physical and psychological examinations, along with a blood sample.
- After admission participants may be asked to stay awake for as long as 20 hours and will be monitored throughout.
- The next morning, participants will be trained to perform a computerized visual discrimination task, and will be tested 8 hours later (after sleep or after remaining awake) on the visual discrimination task.
- Some participants may have PET and MRI scans as part of the study.
- Participants will be able to sleep overnight after they complete the required tests and scans, and will be discharged the following morning.
- Participants will receive financial compensation for their participation in these studies.
Detailed description
The importance of sleep is widely appreciated, but the actual function of sleep remains unknown. Sleep occurs in much of the animal kingdom, in all mammals and birds and even in some lower forms. Sleep deprivation impairs brain function, and in rats, total sleep deprivation for 2-3 weeks results in death. One hypothesized role of sleep is for restoration and reorganization of neuronal circuits. There is some indirect evidence that during sleep, when cerebral energy requirements are reduced, cell resources are diverted to protein synthesis for the restoration of structure and function. The objectives of the present study are: 1) to further define the relationship between regional rates of cerebral protein synthesis (rCPS) and sleep and 2) to ascertain whether sleep-dependent visual learning during slow wave sleep (SWS) results in increases in rCPS in the primary visual cortex. We propose to use a novel positron emission tomography (PET)-based technique to quantify regional rates of cerebral protein synthesis (rCPS) in young, adult, healthy volunteers. The first objective will be addressed in Part I in which we will study each subject under the following three conditions: 1) awake and sleep-sated, 2) awake and sleep-deprived, and 3) during SWS after sleep-deprivation. Our aim is to complete fully successful studies in 15 subjects. The second objective will be addressed in Part II in which we will assess the relationship between rCPS and sleep-dependent visual learning on a retinotopically specific task. Each participant will serve as his own control by comparing the trained primary visual cortex hemisphere with the untrained hemisphere to which comparable visual information is presented but without learning. In Part II we will study two groups of subjects: 1) One group will be studied during SWS following the training session; 2) The second group will be studied at the same interval following the training session but awake. Subjects will be monitored with polysomnography to identify the stages of sleep. Our aim in part II is to complete fully successful studies in 15 subjects in each of the two groups. We anticipate that the results of Part I will identify changes in rCPS in specific brain regions which are characteristic of SWS and results of Part II may reveal relationships between rCPS and memory consolidation during SWS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and female volunteers who have no present or past diagnosis of neurologic, medical or psychiatric conditions which may confound either learning trails, normal sleep patterns or the ability to undergo sleep deprivation.
- Healthy male and female subjects, 18-28 years of age, who do not meet any exclusion criteria, with self-reported normal sleep patterns (i.e., 6-9 h per night) and no major sleep disruptions during the four weeks prior to evaluation will be considered for inclusion in the study.
Key exclusion criteria (14 listed)
- chronic medical condition which is a contraindication for PET or MRI scanning,
- past or present diagnosis of psychiatric conditions (DSM-IV criteria) (many conditions (e.g. depression), may confound performance on learning trails or be associated with baseline sleep abnormalities),
- chronic/degenerative/acquired neurologic disorder, (4) family history of genetically transmissible neurologic disorder,
- sleep disorders or medical conditions associated with chronically disordered sleep which may confound performance on learning trails or interfere with the sleep requirements of this study,
- visual impairments which may confound performance on learning trails,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Regional rates of cerebral protein synthesis
Time frame: 48 hrs
1 secondary outcome
Sleep state and performance on visual discrimination task.
Time frame: 48 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 7718683Armitage R. Microarchitectural findings in sleep EEG in depression: diagnostic implications. Biol Psychiatry. 1995 Jan 15;37(2):72-84. doi: 10.1016/0006-3223(94)00082-E.
- Background: PubMed 18493259Bishu S, Schmidt KC, Burlin T, Channing M, Conant S, Huang T, Liu ZH, Qin M, Unterman A, Xia Z, Zametkin A, Herscovitch P, Smith CB. Regional rates of cerebral protein synthesis measured with L-[1-11C]leucine and PET in conscious, young adult men: normal values, variability, and reproducibility. J Cereb Blood Flow Metab. 2008 Aug;28(8):1502-13. doi: 10.1038/jcbfm.2008.43. Epub 2008 May 21.
- Background: PubMed 8113391Boyle PJ, Scott JC, Krentz AJ, Nagy RJ, Comstock E, Hoffman C. Diminished brain glucose metabolism is a significant determinant for falling rates of systemic glucose utilization during sleep in normal humans. J Clin Invest. 1994 Feb;93(2):529-35. doi: 10.1172/JCI117003.
- Derived from this study: PubMed 26226287McWhirter KK, Morrow AS, Lee BA, Bishu S, Zametkin AJ, Balkin TJ, Smith CB, Picchioni D. A PILOT STUDY ON THE ENCODING OF A PERCEPTUAL LEARNING TASK FOLLOWING SLEEP DEPRIVATION. Percept Mot Skills. 2015 Aug;121(1):80-93. doi: 10.2466/23.PMS.121c11x9. Epub 2015 Jul 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn B Smith, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Mapping, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional rates of cerebral protein synthesis (time frame: 48 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00884702, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.